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Prediction of Outcome After Chemoradiotherapy for Head and Neck Cancer Using Functional Imaging and Tumor Biology

NCT01829646 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-03-31

No results posted yet for this study

Summary

Despite uniform histopathological definition the response of locally advanced squamous cell carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with locoregional recurrences burdening this patient population. The addition of concurrent chemotherapy and the use of altered fractionation schedules has significantly increased locoregional control and overall survival over the last decade however, this has come at the cost of increased acute and late toxicity, preventing further treatment intensification in all patients. If the investigators want to increase the therapeutic index of HNSCC, we need to be able to tailor the treatment more individually to each patient. The project aims at developing a prognostic model for head and neck cancer patients based on the combination of known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging (MRI) obtained before and during treatment. The investigators plan a prospective trial where 120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will be included. Prior to treatment biopsy material will be collected for genetic analysis and before and during treatment functional MRI with diffusion weighted and dynamic contrast enhanced imaging will be performed. All patients will be followed up multidisciplinary afterwards with follow-up of tumor status and toxicity.

Conditions

Interventions

OTHER

functional MRI

Functional MRI on day 22 of the chemoradiotherapy treatment. Parameters of these images will be later on correlated with outcome.

OTHER

Hypoxia gene expression profile.

Tumour biopsies will be obtained as part of the staging procedure (standard). On this biopsies we will conduct a hypoxia gene expression profile (15 genes on PCR that can be analyzed individually or as a group through one binary variable). Hypoxia will be a parameter in our prognostic/predictive model.

OTHER

Functional MRI before start of treatment.

As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with outcome.

Sponsors & Collaborators

  • Flemish League Against Cancer

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Sandra Nuyts, PhD, MD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01829646 on ClinicalTrials.gov